ClinicalTrials.gg
CompletedNCT04449601Updated Jun 29, 2020

Normotensive and Hypertensive Placental Abruptions

An observational study in Abruptio Placentae; Affecting Fetus or Newborn, sponsored by Hatice Akkaya. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-29.

Sponsored by Hatice Akkaya · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
115
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity and mortality. Most abruptions accept to be related to a chronic placental disease process. Therefore, it is very important to understand these processes. To analyze maternal and neonatal effects of placental abruption(PA) through a novel classification in the presence of hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes in addition to hypertension.

Read the detailed description

Objective: We aimed to classify placental abruption according to hypertension status.

Methods: This retrospective cohort designed study was conducted on 115 pregnant women with placental abruption. The main parameters scanned and recorded from the hospital database and patient medical files. Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1 and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care Unit(NICU) were also investigated and compared between the groups.

02

Conditions studied

  • Abruptio Placentae; Affecting Fetus or Newborn

Keywords

  • Abruptio placenta
  • complete blood count
  • hypertension
  • perinatal outcome.
  • mean platelet volume
03

In context

Abruptio Placentae

23 studies on the registry are indexed under Abruptio Placentae; 4 are open to participants now.

This study's enrollment of 115 is below the median of 184 across 12 observational studies indexed under Abruptio Placentae.

Browse Abruptio Placentae studies →

Lead sponsor

Hatice Akkaya is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Two groups were formed according to presence or absence of hypertension (53 hypertensive, 62 normotensive) who has placental abruption.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • spontaneous,
  • singleton pregnancies
  • above 25 weeks of gestations with positive fetal cardiac activity

Exclusion criteria

Exclusion Criteria:

  • multiple gestations,
  • presence of fetal or maternal infection,
  • chronic inflammatory diseases or connective tissue disorders
  • history of myocardial infarction,
  • thrombosis
  • history of drug usage.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
115 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1 (with hypertension )

    Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).

    Other: clinical assesment

  • Group 2( without hypertension)

    Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).

    Other: clinical assesment

Interventions

  • Otherclinical assesment

    Comparison of Hypertensive group and normotensive group

06

What researchers measure

Primary outcomes

  1. blood pressure measurement

    mm Hg

    Time frame: 2 minute

Secondary outcomes

  1. hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)

    complete blood test retrospective complete blood count analysis

    Time frame: first 1 hour

  2. maternal and newborn length, weight

    centimeters,kilogram

    Time frame: 5 minute

  3. APGAR score

    1st and 5th minute newborn assesment

    Time frame: 5 minute

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — The data belonging to participant only will be available to any researcher or editorial review board if needed.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Apr 2017, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2020
First posted
Jun 29, 2020
StartActual
Jan 1, 2016
Primary completionActual
Apr 30, 2017
CompletionActual
Nov 30, 2017
Last update
Jun 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04449601
Lead sponsor
Hatice Akkaya
Responsible party
Hatice Akkaya (Associate Professor, Kayseri Education and Research Hospital) — Sponsor-investigator
First posted
Jun 29, 2020
Start date
Jan 1, 2016
Primary completion
Apr 30, 2017
Completion
Nov 30, 2017
Last update
Jun 29, 2020

Study contacts

Hatice Akkaya, Ass Prof
principal investigator · Kayseri Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion